Ease of doing business in Nigeria has been the mantra of the current administration and to some extent there has been quite some reform on business registration with the corporate affairs commission (CAC) which has completely gone online and has greatly reduced the turnaround time. Although the National Agency for food and Drug administration and control, (NAFDAC) is yet to automate their processes, but with the reforms sweeping across boards, its only a matter of time until it gets automated.
Registering your product with NAFDAC is the second most important thing after establishing and registering your company and product with CAC. It is a criminal act to manufacture, import, export , advertise, sell or distribute a product in Nigeria without registering such. NAFDAC was established to regulate and control the activities relating to food, drugs, cosmetics, medical devices, chemicals and packaged water.
For the records NAFDAC is National Agency for Food and Drug Administration and Control. NAFDAC number on your product gives it better acceptance in the market. For you to register your product with NAFDAC there are quite a number of hurdles to cross and in all it takes three months provided all requirements are met.
The categories of products that can be registered include food, drugs, chemicals, biological, medical devices and cosmetics. And there are guidelines for different product categories and also sub-categories e.g. under food there is guideline for imported food, export of semi-processes food and so on. Check here for the guidelines.
As a case study we are considering registration of local based food and drink, though the process is not so different for other products.
How To Register Your Product With NAFDAC
Go to the NAFDAC office or zonal offices near you to start the process. The first step before you register your product is to have your factory inspected by the Inspection Directorate of NAFDAC. After the inspection, you will be awarded a Certificate of Recognition as a manufacturer, read more here.
After you have been authorized as manufacturer, then purchase and complete the application form prescribed by the agency. It should be noted that you can only register a single product with a form (no group product registration). Note that you to submit three vetting samples of your product to the establishment after a satisfactory inspection. It should be noted also that payments should be made strictly to National Agency for Food and Drug Administration and Control (NAFDAC) and no one else. The tariff is as follows:
To apply for registration you have to write to:
Registration and Regulatory Affairs
Central Laboratory Complex
The application should state the name of the manufacturer, generic name of the product (e.g. biscuit) and brand name of the product.
Submit all necessary documents together with the application to process your registration. The documents to be included are shown in the box below:
When submitting the samples of the product or products please bear in mind the requirement regarding labeling.
Follow these and other guidelines here for you to be get your products registered fast. Any non compliance with the guideline will lead to disqualification or delays in the process.
After submission of all documents, wait for any information from the agency. There might be queries or enquiries that could arise, ensure you respond to such promptly. If you fail to do so especially within the stipulated 30 working days, your application will be suspended indefinitely.
If your application sailed through and you are issued with a Certificate of Registration, you still have to seek approval from the agency before you can advertise it. This is a separate approval. Your certificate could be withdrawn if you advertise without approval. Note also that filling or paying for an application form does not automatically confer the status of registration on you.
A successful application attracts a Certificate of Registration with a validity period of five years whereas products with listing status have a validity of two years.
Check the NAFDAC website for guidelines of other products.
FREQUENTLY ASK QUESTIONS
How long is the registration process?
Three months if all requirements are met as and when due.
How do I begin the process of registration?
You begin with the purchase of the relevant registration application form from the NAFDAC office closest to you and pick up the applicable guidelines.
Where is the NAFDAC registration Office?
In Lagos, with the following addresses.
(a) NAFDAC Central Laboratory Complex
3/4 Oshodi ? Apapa Expressway, Oshodi ? Lagos.
(for Registration and Regulatory Affairs Directorate, Legal Unit, Establishment Inspection Directorate, Food Laboratory, Narcotics and Controlled Substances Directorate).
(b) NAFDAC Central Drug and Vaccines Laboratory (CDVL)
Edmund Crescent, Yaba ? Lagos (for Drug Laboratory and Ports Inspection Directorate).
(c) NAFDAC Enforcement Directorate.
Ahmadu Bello Way (Behind Nigerian Air Force Camp by Legico B/stop), Victoria Island – Lagos.
Whom do I call to report a complaint?
Call the Director (Registration and Regulatory Affairs) on 01-4748627, 01- 4772452
What is NAFDAC?s website and e-mail address?
HOW LONG WILL IT TAKE TO REGISTER MY FOOD PRODUCT?
.The registration of food products takes maximum of three(3) months provided all documents and other requirements as stated in the food registration guidelines are found to be satisfactory
IS THERE ANY CONCESSION IN REGISTRATION TARIFF FOR VARIANTS OF IMPORTED FOOD PRODUCTS?
.YES, registration of food variants e.g. flavour, colour, e.t.c. have concessionary tariff charges
HOW LONG WILL IT TAKE FOR MY PRODUCT REGISTRATION CERTIFICATE TO BE READY?
Product registration certificates takes a maximum of six(6) months after the date of approval to be ready.
CAN I DO TEST MARKETING OF MY PRODUCT BEFORE REGISTRATION?
NO, TEST MARKETING OF FOOD PRODUCTS ARE NOT PERMITTED.
WHAT IS THE AGENCY DOING ABOUT THE LITERING OF THE ENVIRONMENT WITH EMPTY SACHET PACKAGING?
THE AGENCY ENSURES THAT THE SACHET PACKAGING BEARS THE LOGO & INSCRIPTION ?DISPOSE PROPERLY: AND IT IS THE RESPONSIBILITY OF THE MINISTRY OF ENVIRONMENT AT STATE AND LOCAL GOVERNMENT LEVEL TO ENSURE PROPER WASTE DISPOSAL.
CAN PEOPLE NOT JUST PUT NAFDAC NUMBER THAT DOES NOT EXIST ON THEIR OWN?
Yes they do. But they are fake numbers. And they also claim they are going to secure NAFDAC Registration Number very soon. But this is not true.
HOW DO I KNOW THE GENUINE NAFDAC NO.?
Cross check from NAFDAC website, NAFDAC green pages and from NAFDAC offices in all the states of the Federation.
WHERE CAN I FIND THE LIST OF REGISTERED PRODUCTS?
Gazzette, NAFDAC green pages and NAFDAC website, also NAFDAC offices in Nigeria.
WHERE DO I REPORT ANY NEFARIOUS ACTIVITY WHEN PEOPLE ARE TRYING TO FAKE NAFDAC REGULATED PRODUCT?
Report to any NAFDAC office and Enforcement Directorate in Lagos. Call NAFDAC hotlines.
CAN I REGISTER MY PRODUCT MYSELF WITHOUT KNOWING ANYBODY IN NAFDAC OR GOING THROUGH AN AGENT?
HOW DO I KNOW THAT THE NAME I WANT TO USE FOR REGISTRATION OF MY PRODUCT WILL BE ACCEPTED BY NAFDAC?
Write formally to NAFDAC for clearance of Name which can hold for 2 weeks only.
WHEN IS THE PRODUCT LIKELY TO COME OUT OF THE LABORATORY?
WHY CAN’T OUR PRODUCT WHICH IS AN INTERNATIONAL PRODUCT BE ACCEPTED AS SOLD ALL OVER THE WORLD.
Because products must comply with the labeling regulations developed to meet the needs of Nigeria.
HOW AND WHERE ARE CLINICAL TRIALS CONDUCTED?
Clinical trials are conducted in accordance with good clinical practice (GCP) and are conducted in research institutions.
WHAT ARE THE REQUIREMENTS TO CONDUCT CLINICAL TRIALS IN NIGERIA?
The requirements for clinical trials can be obtained from our website: www.nafdacnigeria.gov.ng.
ARE CLINICAL TRIALS DIRECTLY SUPERVISED BY NAFDAC?
DO FOREIGN DRUGS GET SUBJECTED TO CLINICAL TRIALS BEFORE THEY ARE ALLOWED FOR USE IN THE COUNTRY?
Yes. Particularly if the drug does not have adequate and well documented use in black population or it has some race specific properties or its efficacy, safety and usefulness needs to be proven in our population.
DO NAFDAC CHOOSE INVESTIGATORS TO CONDUCT CLINICAL TRIALS?
No. Sponsors and applicants are responsible for the choice of their trial investigators.
HOW MANY STUDY SITES ARE CLINICAL TRIALS ARE SUPPOSED TO BE CONDUCTED?
At least two centers.
HOW LONG DOES IT TAKE TO CONDUCT CLINICAL TRIALS?
It depends on t a number of factors, some of which are:
? The design of the trial.
? The nature of the investigational product.
? The investigational product.
? The rate of recruitment of trial participants, etc.
HOW MANY PEOPLE ARE SUPPOSED TO PARTICIPATE IN CLINICAL TRIALS?
The number of participants to be involved in a study depends on the phase of the study (I, II, III or IV) and the trial design.
HOW MUCH DOES IT TAKE TO CONDUCT CLINICAL TRIAL IN NIGERIA?
The applicant need to pay NAFDAC N200, 000.00 plus 5% VAT for imported products and N50, 000.00 plus 5%VAT for local and herbal products. Other monetary expenses related to the conduct of the trial are handled between the sponsors and the investigators.
HOW MANY DRUGS ARE CURRENTLY UNDERGOING CLINICAL TRIALS NOW?
LIST OF BANNED FOOD COLOURS AND / OR ADDITIVES.
This is in accordance with Codex, EU, and FDA list of Banned Colours and / or food additives. This is usually downloaded On www.codexalimentarius.net, www.fda.gov , and www.eu.net .
CODEX LIST OF FOOD CONTAMINANTS AND MAXIMUM LIMIT IN DIFFERENT CATEGORIES OF FOODS
This is in accordance with Codex, EU, and USFDA position on maximum limit of contaminants in foods. However, in some cases it depends on country?s position as some external factors can contribute to high values of contaminants in foods. These values can be downloaded on the websites given above.